Acetaminophen

Product NDC: 71335-9746
11-digit product format: 713359746
Labeler code: 71335
Product ID: 71335-9746_61ea1796-b9c7-4cb9-9a36-60943f884875
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen tablet extended release
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA215486
Marketing category: ANDA
Marketing start: 2021-10-04
Substance: ACETAMINOPHEN
Active strength: 650 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215486-001	ACETAMINOPHEN	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL			2021-08-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215486-001	ACETAMINOPHEN	650MG	TABLET, EXTENDED RELEASE / ORAL	2021-08-25	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1148399	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
61ea1796-b9c7-4cb9-9a36-60943f884875	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-9746-1	Acetaminophen	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	101
71335-9746-2	Acetaminophen	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	101
71335-9746-3	Acetaminophen	50 in 1 BOTTLE	TABLET, EXTENDED RELEASE	50	101
71335-9746-4	Acetaminophen	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	101
71335-9746-5	Acetaminophen	120 in 1 BOTTLE	TABLET, EXTENDED RELEASE	120	101
71335-9746-6	Acetaminophen	19 in 1 BOTTLE	TABLET, EXTENDED RELEASE	19	101
71335-9746-7	Acetaminophen	20 in 1 BOTTLE	TABLET, EXTENDED RELEASE	20	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9746	ACETAMINOPHEN (ACETAMINOPHEN TABLET EXTENDED RELEASE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]	101	Current NDC, 7 package rows	20240410_61ea1796-b9c7-4cb9-9a36-60943f884875.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8HR Arthritis Pain Relief	ACETAMINOPHEN 650MG	CVS Pharmacy	2eb6eba1-46af-32a4-e063-6294a90a499c	2026-04-28	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain	ACETAMINOPHEN	SAM'S WEST INC	3928090d-b45e-6948-e063-6394a90a47dd	2025-08-11	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8HR Arthritis Pain Relief	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	331f907a-0fb6-e23d-e063-6394a90a2db1	2025-06-22	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8HR Muscle Aches and Pain Relief	ACETAMINOPHEN	LEADER/ Cardinal Health 110, Inc.	331f4bd1-1303-cc48-e063-6394a90a74d3	2025-06-03	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain Relief	ACETAMINOPHEN	KROGER COMPANY	0fec22a3-aad0-8c28-e063-6394a90adc18	2025-05-10	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8hr arthritis pain relief	ACETAMINOPHEN	Major Pharmaceuticals	31b3aaa2-8af2-670a-e063-6394a90a8003	2025-05-03	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 HR MUSCLE ACHES AND PAIN	ACETAMINOPHEN	CVS Pharmacy	2eb6fc42-6ba4-8f58-e063-6294a90ac6a0	2025-04-28	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	Asclemed USA, Inc.	4ef6bc2b-03cf-474f-bb9e-dbb5792ec197	2025-02-24	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 Hour Pain Relief	ACETAMINOPHEN	KROGER COMPANY	0fec5c67-8d5d-8e45-e063-6394a90a982a	2024-04-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	Bryant Ranch Prepack	61ea1796-b9c7-4cb9-9a36-60943f884875	2024-04-05	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486 ndc (product): 71335-9746
Acetaminophen	ACETAMINOPHEN TABLET EXTENDED RELEASE	TIME CAP LABORATORIES, INC.	cd4d0ad4-7206-94c8-e053-2a95a90aaa14	2024-03-19	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain Acetaminophen	ACETAMINOPHEN	TARGET CORPORATION	c8025c83-77a1-c0dd-e053-2995a90a838d	2024-03-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8HR Pain Relief	ACETAMINOPHEN	TARGET CORPORATION	e8b48f37-6023-ba04-e053-2a95a90a0e6c	2024-03-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain Reliever	ACETAMINOPHEN	WALGREENS	e71f632f-37dd-49c0-e053-2a95a90a67d7	2024-03-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Acetaminophen Extended-Release Tablets, 650 mg	ACETAMINOPHEN	MARKSANS PHARMA LIMITED	d973a910-5fe0-4a85-884d-2c3987836691	2023-10-17	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
Arthritis Pain	ACETAMINOPHEN	BETTER LIVING BRANDS, LLC	ee84323a-b615-3ec6-e053-2995a90a5a26	2023-06-15	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 hr Arthritis Pain Relief	ACETAMINOPHEN	DOLGENCORP, INC.	ea2eae7c-e9bd-534c-e053-2a95a90a26c8	2023-04-20	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486
8 hr Pain Relief	ACETAMINOPHEN	DOLGENCORP, INC.	ea2ebb7b-ceab-567a-e053-2995a90aa402	2023-04-20	Warnings	Exact identifier application applno (ANDA): 215486 application number: ANDA215486

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1148399	acetaminophen 650 MG 8HR Extended Release Oral Tablet	PSN	61ea1796-b9c7-4cb9-9a36-60943f884875	101
1148399	8 HR acetaminophen 650 MG Extended Release Oral Tablet	SCD	61ea1796-b9c7-4cb9-9a36-60943f884875	101
1148399	8 HR APAP 650 MG Extended Release Oral Tablet	SY	61ea1796-b9c7-4cb9-9a36-60943f884875	101
1148399	acetaminophen 650 MG 8 HR Extended Release Oral Tablet	SY	61ea1796-b9c7-4cb9-9a36-60943f884875	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-9746-1	71335974601	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-1)	2023-11-16	No	No	Current
71335-9746-2	71335974602	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-2)	2024-04-05	No	No	Current
71335-9746-3	71335974603	50 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-3)	2024-04-05	No	No	Current
71335-9746-4	71335974604	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-4)	2024-04-05	No	No	Current
71335-9746-5	71335974605	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-5)	2024-04-05	No	No	Current
71335-9746-6	71335974606	19 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-6)	2024-04-05	No	No	Current
71335-9746-7	71335974607	20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-7)	2024-04-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Timely 699R 704R Acetaminophen Extended-Release Tablets USP, 650 mg	Bryant Ranch Prepack	2024-04-05	HUMAN OTC DRUG LABEL	101